QMS Coach
Queen Margaret's School
Queen Margaret's School offers an innovative, independent Preschool to Grade 12 education in British Columbia, fostering academic excellence, arts, athletics, and equestrian training for young trailblazers.
Queen Margaret's School is an independent Preschool to Grade 12 day and boarding school located in Duncan, British Columbia, dedicated to providing an outstanding education since 1921. We empower students through an innovative curriculum and enhanced programs in academics, athletics, fine arts, equestrian training, and service, ensuring every child feels safe, accepted, and respected. Our comprehensive programs cater to diverse interests, from Early Childhood Education and Recreational & Competitive programs for Grades 4-12, to specialized Senior and Junior School Academics, Athletics, and a renowned Boarding Program. We also offer robust Arts Programs and Post-Secondary Guidance to prepare students for their future. For aspiring equestrians, Queen Margaret's School provides exceptional Equestrian Education, including Rider Development, School Horse Programs, and a High Performance Foundations Program, complemented by various Equestrian Events. The Admissions Team is readily available to assist with the application process, school fees, scholarships, bursaries, and international resources, ensuring a smooth journey for prospective families.
About
**Who they are**
QMS Coach provides expertise in the FDA's Quality Management System Regulation (QMSR) transition, helping medical device companies navigate the shift from the Quality System Regulation (QSR). They focus on practical implementation and understanding the nuances of the new regulatory framework.
**Expertise & scope**
* **QMSR Transition:** Guidance on the transition to QMSR, which replaces the QSR on February 2, 2026, and incorporates ISO 13485:2016 into US law.
* **Supplier Quality:** Detailed insights into QMSR supplier quality requirements, emphasizing a risk-based approach and the increased scrutiny of supplier audit records by the FDA.
* **Terminology & Definitions:** Clarification of QMSR terminology, including changes from QSR and the hierarchy of definitions from multiple sources.
* **US-Only Companies:** Playbooks and guidance specifically addressing the unique challenges faced by US-only medical device companies transitioning to QMSR.
* **Timeline Management:** Assistance in understanding critical dates and developing transition milestones before the February 2, 2026 deadline.
* **Key Differences:** Analysis of the 15 critical differences between QMSR and QSR, highlighting areas requiring immediate operational changes.
**Reputation / proof points**
* Offers a QMSR Readiness Self-Assessment tool.
* Provides guides and playbooks for QMSR transition.
QMS Coach provides expertise in the FDA's Quality Management System Regulation (QMSR) transition, helping medical device companies navigate the shift from the Quality System Regulation (QSR). They focus on practical implementation and understanding the nuances of the new regulatory framework.
**Expertise & scope**
* **QMSR Transition:** Guidance on the transition to QMSR, which replaces the QSR on February 2, 2026, and incorporates ISO 13485:2016 into US law.
* **Supplier Quality:** Detailed insights into QMSR supplier quality requirements, emphasizing a risk-based approach and the increased scrutiny of supplier audit records by the FDA.
* **Terminology & Definitions:** Clarification of QMSR terminology, including changes from QSR and the hierarchy of definitions from multiple sources.
* **US-Only Companies:** Playbooks and guidance specifically addressing the unique challenges faced by US-only medical device companies transitioning to QMSR.
* **Timeline Management:** Assistance in understanding critical dates and developing transition milestones before the February 2, 2026 deadline.
* **Key Differences:** Analysis of the 15 critical differences between QMSR and QSR, highlighting areas requiring immediate operational changes.
**Reputation / proof points**
* Offers a QMSR Readiness Self-Assessment tool.
* Provides guides and playbooks for QMSR transition.
Additional information
For companies operating solely within the US market, the QMSR transition presents unique challenges, particularly regarding the integration of ISO 13485:2016 into federal law. QMS Coach addresses these specific gaps, such as the need for combined CAPA procedures, inspection-ready management review and internal audit records, and formal customer communication and feedback systems. They emphasize leveraging existing QSR foundations while preparing for the new requirements. Buyers should consider their readiness for a more explicit risk-based approach to supplier management, as QMSR places greater emphasis on this compared to the previous QSR.
Key Highlights
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Offers a QMSR Readiness Self-Assessment tool to gauge QMS compliance.
Source
“Answer 12 questions to gauge your QMS readiness for FDA's QMSR framework.”
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Provides a complete management guide for QMSR supplier quality requirements, emphasizing a risk-based approach.
Source
“Supplier quality management under QMSR is more explicitly risk-based than under QSR.”
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Details the 15 critical differences between QMSR and QSR, focusing on operational changes.
Source
“Here are the 15 differences that require actual operational changes—not just terminology updates.”
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Offers a playbook specifically for US-only companies transitioning to QMSR.
Source
“This playbook addresses the specific challenges faced by US-only medical device companies transitioning to QMSR.”
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Provides a timeline of critical QMSR dates and recommended transition milestones before February 2026.
Source
“This article provides a comprehensive timeline of QMSR-related dates, recommended milestones for your transition...”
Certifications & Trust Signals
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Focuses on QMSR compliance, a critical regulatory requirement for medical device manufacturers.
Source
“Ready to be QMSR-compliant before Feb 2, 2026?”
Buyer Snapshot
Best for
- Medical device companies preparing for QMSR compliance.
- US-only companies needing to understand ISO 13485 integration.
- Organizations seeking clarity on QMSR terminology and supplier requirements.
How engagement typically works
- Provides self-assessment tools.
- Offers detailed guides and playbooks.
- Focuses on practical implementation and gap analysis.
Typical deliverables
- QMSR readiness assessments.
- Transition playbooks.
- Supplier quality requirement guides.
- Terminology glossaries.
Good to know
- Best when a clear understanding of the February 2, 2026 deadline is a priority.
Pricing
Model:
Custom pricing
HQ:
Duncan, Canada
Languages:
English
Timezones:
EST, PST
Status:
listed
Services & Capabilities
FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, IVD
Onboarding time:
7–21 days
Pricing model:
Custom pricing
Service Types:
Mock FDA Inspection
Additional fda_qmsr_transition_inspection_readiness Details
Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, Supplier Controls/Quality Agreements, Training & Competency Programs
Earliest Start
flexible
Delivery Mode
Remote
Inspection Experience
Supports mock inspections regularly
